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Ergometer Training in Patients With OSA

NCT ID: NCT01457729

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-12-31

Brief Summary

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Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard bike ergometer which is additionally equipped with a system to gather training data and the ability to send daily training time to an internet server to which the physician has access. Training time of two groups is compared. Group one is not motivated while group two benefits from telephone feedback when training time declines. It is presumed that training time increases with better information and response to training behaviour.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Keywords

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ergometer training motivation telemonitoring sleep apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Motivation

Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes per day, no more intervention is done.

Group Type NO_INTERVENTION

No interventions assigned to this group

Motivation

Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes every day. If training time declines to less than 20 minutes per day for one week, a motivation phone call will take place once a week.

Group Type OTHER

Motivation by Telephone Call

Intervention Type BEHAVIORAL

Telephone call not exceeding 10 minutes according to a protocol

Interventions

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Motivation by Telephone Call

Telephone call not exceeding 10 minutes according to a protocol

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Suspected OSA
2. Capable of giving consent

Exclusion Criteria

1. Symptomatic cardial infarction
2. Decompensated cardiac insufficiency
3. Hemodynamically effective cardiac arrhythmias
4. Hemodynamically significant Vitia (heart disease)
5. Insufficiently regulated arterial hypertension
6. Global respiratory insufficiency
7. Significant partial insufficiency (PAO2 \<50mmHg or SaO2 \< 80% at rest)
8. State after decompensation of Cor Pulmonale
9. Right ventricular strain at pulmonary hypertension at rest (pulmonary arterial pressure \> 20 mmHg)
10. Severe osteoporosis
11. Higher degree of lung functional restriction: FEV1 \<50% oder \>60% of nominal value after bronchospasmolysis
12. Working performance on ergometer \< 50%
13. Unstable bronchial asthma
14. Exacerbated COPD
15. Heavily overweight (BMI \>40 or weight \>140kg)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Heinz Ruehle, Prof

Role: PRINCIPAL_INVESTIGATOR

Institut für Pneumologie Hagen Ambrock eV

Locations

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Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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ERGO2011

Identifier Type: -

Identifier Source: org_study_id